Next week, a panel of doctors is due to advise the FDA on whether Avandia should be yanked from the market. Ahead of the meeting, a panel of reviewers issued a scathing report that recommends in no uncertain terms that Avandia be yanked.
Avandia is no more effective at improving glycemic control in type 2 diabetes compared with Actos, and provides no known unique health benefits. While both drugs increase the risk of congestive heart failure, Avandia's effect on CHF is "substantially greater," FDA reviewers wrote in a massive briefing document released Friday.
"Our review of the literature finds no evidence of a unique or meaningful health benefit from rosiglitazone [Avandia] that is not also provided by pioglitazone [Actos] and there is substantial evidence that rosiglitazone increases cardiovascular risk compared with pioglitazone," the reviewers said.
The reviewers not only shredded the logic of the 2007 decision to let Avandia stay on the shelves, but accused GlaxoSmithKline of manipulating data in the Record trial which supposedly gave Avandia a clean bill of health.
FDA reviewer Thomas Marciniak took a close look at the Record trial and concluded that Glaxo badly misinterpreted the data.
Correctly interpreted, the study actually supports critics’ contentions that Avandia may cause heart attacks, said the reviewer, Dr. Thomas Marciniak, in a posting on the F.D.A.’s Web site.
The company’s misreadings of the study, known as the Record trial, were so profound, he concluded, that they "suggest serious flaws with trial conduct."
"One does not have to be a mathematician or to perform calculations," he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks.
The review goes even further than that, presenting four cases of what it calls "extreme mishandling of events." It also found that TIDE, Glaxo's outcomes trial comparing Avandia to Actos, was unethical and exposes patients to unnecessary risks.
Bottom line? Unless there's something we don't know, Avandia's days are numbered.
Full report is available here.